Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name Instrument, Biopsy
510(k) Number K222865
Device Name M Biopsy /SureCore Automatic Disposable Biopsy Needle, M Biopsy /SureCore Semi-Automatic Disposable Biopsy Needle, M Biopsy /SureAim Coaxial Biopsy Needle
Applicant
Canyon Medical Inc.
Building 3, Phase 2 Accelerator, No. 11 Yaogu Avenue
Jiangbei New Area
Nanjing,  CN 210032
Applicant Contact Huiqi Jiang
Correspondent
Canyon Medical Inc.
Building 3, Phase 2 Accelerator, No. 11 Yaogu Avenue
Jiangbei New Area
Nanjing,  CN 210032
Correspondent Contact Huiqi Jiang
Regulation Number876.1075
Classification Product Code
KNW  
Date Received09/22/2022
Decision Date 04/03/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-